Hypermobile Ehlers-Danlos SyndromeNCT04666896
Patient-based Care Versus Standard Care for Patients With hEDS/HSD and Multidirectional Shoulder Instability
A study testing Tailored home-based exercise therapy and Standard home-based exercise therapy in people with Hypermobile Ehlers-Danlos Syndrome and Hypermobility Syndrome, run by University Ghent at 1 site in Belgium.
Trial summary
For hEDS or HSD patients with MDI, a multidisciplinary treatment approach is suggested. As follows, physiotherapy plays a key role in this integrative management. Nevertheless, knowledge regarding EDS is limited among health care professionals. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hypermobile Ehlers-Danlos Syndrome, Hypermobility Syndrome, Multidirectional Subluxation of Shoulder
- What is being tested?
- Tailored home-based exercise therapy and Standard home-based exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 9 May 2019to 9 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 18-65 years
- Patients diagnosed by a medical doctor with generalized HSD or hEDS, according to the diagnostic criteria for hEDS and HSD as stated in the recently published international classification for the Ehlers-Danlos syndromes
- Patients diagnosed with multidirctional shoulder instability (MDI): The diagnosis of MDI was confirmed when 1) patients reported symptoms of shoulder instability in daily life (e.g. recurrent subluxations) without a traumatic onset; 2) patients scored positive on shoulder laxity and instability tests (i.e. sulcus sign, anterior and posterior load and shift, posterior jerk, Gagey hyperabduction test, passive and active external rotation in supine, apprehension and relocation test) in at least two directions; 3) patients had shoulder pain for at least three months prior to the study.
Who cannot join
- pregnancy during study participation
- patients who started a new physiotherapeutic treatment in the 2 weeks prior to the study
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University, department of rehabilitation sciences
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: Effectiveness of a 6-month Home-based Exercise Program for Treating Shoulder Instability in Patients With Hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): A Pilot Randomized Controlled Trial.
For hEDS or HSD patients with MDI, a multidisciplinary treatment approach is suggested. As follows, physiotherapy plays a key role in this integrative management. Nevertheless, knowledge regarding EDS is limited among health care professionals. Consequently, evidence-based treatment approaches for the hEDS/HSD population are scarce. Therefore, the aim of this study is to compare two different home-based exercise programs in order to increase our knowledge regarding treatment options, and to gain insight in safe, effective exercises for the unstable shoulder in this study population.
Read the detailed description
The main purpose of this study was to evaluate the value of two telerehabilitation exercise programs for treating multidirectional shoulder instability (MDI) in patients diagnosed with the hypermobile type of The Ehlers-Danlos syndrome (hEDS) or Hypermobility Spectrum Disorders (HSD). Patients were randomly assigned to either the control group (B: evidence-based tailored care) or the experimental group (A: evidence-based standard care). Both groups received a home-based exercise program of 24 weeks. The primary outcome measure was the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH), Tampa Scale for Kinesiophobia (TSK), Patient-Specific Functional Scale (PSFS), Global Rating of Change (GROC), and pain pressure thresholds (PPTs). Outcomes were assessed at baseline, after 6 weeks, 12 weeks, and at the end of the study (24 weeks).
- Conditions
- Hypermobile Ehlers-Danlos Syndrome, Hypermobility Syndrome, Multidirectional Subluxation of Shoulder
- Being tested
- Tailored home-based exercise therapy, Standard home-based exercise therapy
- Keywords
- Hypermobile Ehlers-Danlos syndrome, Hypermobility Spectrum Disorder, Mutlidirectional shoulder instability, Telerehabilitation
- Medical subject headings
- Ehlers-Danlos syndrome type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored home-based exercise therapyOther
exercises were divided into four types: 1) shrug exercises; 2) external rotation exercises; 3) bench slides; and 4) wall slides.
Standard home-based exercise therapyOther
The exercise program consisted of 4 types of exercises for training 1) balance and proprioception; 2) isometric strength; 3) rotator cuff muscles; and 4) open chain elevation
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based tailored care (group A) | Experimental | Patients who were randomized to group A received a tailored exercise program, with exercises developed based on recent hEDS/HSD research data. Receives: Other: Tailored home-based exercise therapy |
| Evidence-based standard care (group B) | Active comparator | This exercise program was composed in order to reflect evidence-based standard care, in a telerehabilitation format. Receives: Other: Standard home-based exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario Shoulder Instability Index (WOSI)
The WOSI is a responsive patient-reported and disease-specific tool, designed to be used as the primary outcome measure in clinical trials that assess treatments for patients with shoulder instability. Range 0 - 2100 points. Higher scores express worse status.
Measured: Measured at baseline, 6 weeks, 12 weeks and 24 weeks, in order to assess the change in WOSI from baseline to 6 weeks, 12 weeks, and 24 weeks
Secondary outcomes (5)
The Disabilities of the Arm Shoulder and Hand (DASH)
The DASH is a region-specific questionnaire of upper extremity disability (range 0-100). Higher scores express worse status
Measured: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
The Tampa Scale for Kinesiophobia (TSK)
The TSK is one of the most frequently used measures for evaluating general pain-related fear of movement. Range 17 - 68 points. Higher scores express worse status.
Measured: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
The Patient-Specific Functional Scale (PSFS)
The PSFS is a patient-rated outcome measure designed to evaluate functional change. Patients were asked to identify 3 activities they were having difficulty with as a result of their shoulder instability, and to rate each activity on an 11-point Likert scale (0 = impossible to perform the activity; 10 = able to perform the activity without complaints or help). At each follow-up moment, the same 3 activities were rated. The total PSFS score was calculated by adding the scores for the 3 activities. Range 0-30 points. Higher scores express better status.
Measured: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
The Global Rating of Change (GROC)
The GROC is a transitional scale used to quantify patient-perceived improvement. It can be used to assess the results of treatment since it defines the change in health status as perceived by the patient. We asked patients to rate whether or how much their shoulder has changed since the beginning of the study on a 11 point numerical scale ('How would you describe the change in your shoulder since the beginning of the treatment program?' with -5= a lot worse; 0 = unchanged; +5= fully recovered). Range -5 to 5 points. Higher scores express better status.
Measured: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Pain pressure thresholds (PPT)
PPTs were measured on five locations around the shoulder (local PPTs). Additionally, a distal PPT was measured at the midpoint of the quadriceps muscle.
Measured: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start9 May 2019
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Why it stopped: Due to COVID-19, this pilot study ended prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobile Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fransiska Malfait, Prof. Dr., Principal investigator, Centre of Medical Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666896
- Sponsor's protocol ID
- B670201939864
- Other IDs
- BOF17/DOC/220
- Status last verified
- Mar 2021
- First submitted
- 8 Dec 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a 6-month Home-based Exercise Program for Treating Shoulder Instability in Patients With Hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): A Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04666896
- Acronym / sponsor ID
- B670201939864
- Conditions
- Hypermobile Ehlers-Danlos Syndrome, Hypermobility Syndrome, Multidirectional Subluxation of Shoulder
- Keywords
- Hypermobile Ehlers-Danlos syndrome, Hypermobility Spectrum Disorder, Mutlidirectional shoulder instability, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19, this pilot study ended prematurely.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For hEDS or HSD patients with MDI, a multidisciplinary treatment approach is suggested. As follows, physiotherapy plays a key role in this integrative management. Nevertheless, knowledge regarding EDS is limited among health care professionals. Consequently, evidence-based treatment approaches for the hEDS/HSD population are scarce. Therefore, the aim of this study is to compare two different home-based exercise programs in order to increase our knowledge regarding treatment options, and to gain insight in safe, effective exercises for the unstable shoulder in this study population.
Detailed description
The main purpose of this study was to evaluate the value of two telerehabilitation exercise programs for treating multidirectional shoulder instability (MDI) in patients diagnosed with the hypermobile type of The Ehlers-Danlos syndrome (hEDS) or Hypermobility Spectrum Disorders (HSD). Patients were randomly assigned to either the control group (B: evidence-based tailored care) or the experimental group (A: evidence-based standard care). Both groups received a home-based exercise program of 24 weeks. The primary outcome measure was the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH), Tampa Scale for Kinesiophobia (TSK), Patient-Specific Functional Scale (PSFS), Global Rating of Change (GROC), and pain pressure thresholds (PPTs). Outcomes were assessed at baseline, after 6 weeks, 12 weeks, and at the end of the study (24 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidence-based tailored care (group A) | Experimental | Other: Tailored home-based exercise therapyPatients who were randomized to group A received a tailored exercise program, with exercises developed based on recent hEDS/HSD research data. |
| Evidence-based standard care (group B) | Active comparator | Other: Standard home-based exercise therapyThis exercise program was composed in order to reflect evidence-based standard care, in a telerehabilitation format. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 18-65 years
- Patients diagnosed by a medical doctor with generalized HSD or hEDS, according to the diagnostic criteria for hEDS and HSD as stated in the recently published international classification for the Ehlers-Danlos syndromes
- Patients diagnosed with multidirctional shoulder instability (MDI): The diagnosis of MDI was confirmed when 1) patients reported symptoms of shoulder instability in daily life (e.g. recurrent subluxations) without a traumatic onset; 2) patients scored positive on shoulder laxity and instability tests (i.e. sulcus sign, anterior and posterior load and shift, posterior jerk, Gagey hyperabduction test, passive and active external rotation in supine, apprehension and relocation test) in at least two directions; 3) patients had shoulder pain for at least three months prior to the study.
Key exclusion criteria (2 listed)
- pregnancy during study participation
- patients who started a new physiotherapeutic treatment in the 2 weeks prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored home-based exercise therapyexercises were divided into four types: 1) shrug exercises; 2) external rotation exercises; 3) bench slides; and 4) wall slides. | Other | Evidence-based tailored care (group A) |
| Standard home-based exercise therapyThe exercise program consisted of 4 types of exercises for training 1) balance and proprioception; 2) isometric strength; 3) rotator cuff muscles; and 4) open chain elevation | Other | Evidence-based standard care (group B) |
Primary outcome
Change in Western Ontario Shoulder Instability Index (WOSI)
Time frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks, in order to assess the change in WOSI from baseline to 6 weeks, 12 weeks, and 24 weeks
The WOSI is a responsive patient-reported and disease-specific tool, designed to be used as the primary outcome measure in clinical trials that assess treatments for patients with shoulder instability. Range 0 - 2100 points. Higher scores express worse status.
5 secondary outcomes
The Disabilities of the Arm Shoulder and Hand (DASH)
Time frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
The Tampa Scale for Kinesiophobia (TSK)
Time frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
The Patient-Specific Functional Scale (PSFS)
Time frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
The Global Rating of Change (GROC)
Time frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Pain pressure thresholds (PPT)
Time frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Results and safety
The study was stopped early (reason given: Due to COVID-19, this pilot study ended prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fransiska Malfait, Prof. Dr. principal investigator
Centre of Medical Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored home-based exercise therapy and Standard home-based exercise therapy in people with Hypermobile Ehlers-Danlos Syndrome and Hypermobility Syndrome, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19, this pilot study ended prematurely.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario Shoulder Instability Index (WOSI) (time frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks, in order to assess the change in WOSI from baseline to 6 weeks, 12 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.